This study sets out to test the hypothesis that parameters of heart rate variability, as a non-invasive measure of cardiovascular risk, can be improved by the addition of omega-3 fatty acids in euthymic bipolar patients with a low omega-3 index and reduced heart rate variability.

The corn oil capsules look exactly the same as the capsules containing omega-3 fatty acids. For the entire study period patients will receive 4 capsules of corn oil per day.

Experimental: Omega-3 fatty acids

Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG)

The study drug is a food supplement called EPAX 6015 TG. One capsule of EPAX 6015 TG contains 530 mg of EPA (eicosapentaenoic acid) and 150 mg of DHA (docosahexaenoic acid), provided as triglycerides. For the entire study period (12 weeks) patients will receive 4 capsules of EPAX 6015 TG per day.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects must meet the DSM-IV criteria for bipolar disorders, in remission

Age: 18 - 65 years

Low omega-3 index (<5%)

SDNN < 60 msec

Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews and fill out the Beck Depression Inventory

Stable psychotropic medication for at least 2 weeks

Subjects must be able to give written informed consent

Exclusion Criteria:

Subjects for whom the intake of omega-3 fatty acids is indicated according to recent treatment guidelines

Patients on Warfarin

Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction, stroke, embolism

Subjects with significant medical comorbidity

Pregnant subjects - due to any possible teratogenic effects of EPAX 6015 TG and corn oil, respectively, on the fetus - and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded

Subjects who, in the investigator's judgement, pose a current significant suicidal or homicidal risk or patients who will not likely be able to comply with the study protocol

Subjects fulfilling the DSM-IV diagnostic criteria for current substance abuse

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891826